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临床试验/NCT02361840
NCT02361840Unknown不适用

Predictive Value of Troponin I for Acute Respiratory Distress Syndrome in Children With Shock

Hospital Civil de Guadalajara1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
65
试验地点
1
主要终点
Determination of results of Primary study cohort

研究概览

简要总结

Shock is one of the five leading causes of income and mortality in emergencies. It generates a decrease in the availability of oxygen to the tissues, resulting in ischemia, pulmonary involvement and tissue reperfusion syndrome. This pathologies can trigger Syndrome of Acute Respiratory Distress (ARDS) and death.

Troponin I (TI) has been reported as early marker for ischemia and mortality other than coronary syndromes in critical patients.

Objective. Set the increase of TI as a predictor of ARDS in children with shock.

Null hypothesis. Increase serum in children with shock predicts the onset of ARDS.

Methodology. Prospective cohort type test diagnostic. Displays institutional. Sampling non-probability, consecutive inclusion. Calculation of the sample size: interval of confidence (IC) 95%, power - 80%; ratio non-exposed: exposed 2:1; n = 62.

Inclusion criteria: informed consent signed by the parent; children admitted to pediatric emergency (PEU) 1 month to 14 years with shock requiring mechanical ventilation.

Exclusion criteria: intake of toxic (TI value increment per will), ≥3 concentrated erythrocyte transfusion or plasma prior to entering PEU.

The investigators call exposure to the increase of TI≥0 05ng/ml and event to the development of ARDS. Determine TI value in plasma serum in the first 24 h, through Enzyme Immunoassay for the Quantitative Determination of Cardiac-Specific Troponin-I in Human Serum (cTnI ELISA), (reported as cardiac triage). Monitoring for 7 days.

Study was approved by Hospital Ethics Committee (Research record 003/12)

详细描述

INTRODUCTION The purpose of the present study is to establish a Troponin I (TI) in peripheral blood as a prognostic indicator in the emergence of the syndrome of acute respiratory difficulty (ARDS) in children with shock.

It should be noted that both shock and ARDS are life-threatening disease and one can trigger another (shock first then ARDS or ARDS then shock). Both involve abnormalities in blood flow (perfusion) tissues that leads to cellular stress, reduction of oxygen suplly (hypoxia), nutrients, consenquently generating an increase in tissue´s metabolic demands. This set of events is called ischemia.

The shock is a dynamic clinical syndrome of acute and complex circulatory dysfunction, caused by severe illness or trauma. To perpetuate itself generates multiple organ dysfunction and death. Regardless of its cause, it is conceptualized as a state of acute oxygen deficiency that prevents cell sustainability. The shock is one of the five leading causes of admission to emergency Pediatrics unit (EPU) of the Hospital Civil de Guadalajara "Fray Antonio Alcalde" (HCFAA).

Shock is the second cause of mortality in patients in the EPU. ARDS is an acute and diffuse, pulmonary inflammatory lesion characterized by increased pulmonary vascular permeability, weight and the decrease ventilation on the lung tissue. The specific clinical elements are hypoxemia and bilateral radiographic opacities associated with increases in the mixture of venous blood, physiological dead space and reduction of the pulmonary compliance. Diffuse alveolar damage is the morphological element that is in the acute phase (e.g. swelling, inflammation, hyaline membrane or bleeding). It has a mortality rate of 30-50% in the world.

TI is a protein that is determined in blood only under pathological conditions; mainly increases when there is myocardial ischemia. It was used in the first instance to diagnose acute coronary syndromes as ischemia, coronary angina pectoris and acute myocardial infarction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Informed consent signed by the parent to participate in the study.
  • Children admitted to EUP the HCFAA of 1 month old 14 years showing shock with less than 24 hour evolution.
  • Need for endotracheal intubation and mechanical ventilation.

排除标准

  • Intake of toxic tricyclic antidepressants, cocaine and methamphetamines that increase value of TI per se.
  • Transfusion three or more concentrated erythrocyte / plasma before entering UP.
  • Pregnant girls
  • Children with a previous diagnosis of uremic kidney injury

结局指标

主要结局

Determination of results of Primary study cohort

时间窗: 2 years

incidence of exposed , unexposed incidence , relative risk, attributable risk , absolute risk reduction

次要结局

  • Diagnostic Test(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

KARLA ISIS AVILES MARTINEZ

MD Karla Isis Aviles Martinez

Hospital Civil de Guadalajara

研究点 (1)

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